Evaluation of negative pressure incisional therapy in urgent gastro-intestinal surgery for reduction of superficial surgical site infections compared to non-occlusive conventional plaster -A prospective, randomized, controlled, multicenter clinical trial
Not Applicable
- Conditions
- Comparison of negative pressure incisional therapy with conventional plaster in regard to post-surgical site infections after urgent laparotomies in acute cases of gastro-intestinal disorders.
- Registration Number
- DRKS00011033
- Lead Sponsor
- Philipps-Universität Marburg
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
•Patients with indication for urgent laparotomy due to an acute gastro-intestinal disorder
•age = 18 years
•life expectancy > 12 months
•Written informed consent of the patient or the patient’s legal representative
Exclusion Criteria
•Inpatient treatment longer than 4 days before urgent surgery
•Previous transverse or median laparotomy, if it is necessary to reopen it again
•Allergy or hypersensitivity against silver or acrylic adhesives
•pregnancy
•participation in an interventional study with interfering endpoints
•neurophysiological deficits
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of post-surgical site infections of category A1 (superficial) and A2 (deep) within 30 (+7) days after surgery in patients without revision.
- Secondary Outcome Measures
Name Time Method Prolongation of hospitalisation due to post-surgical site infection, <br>cosmetic result, <br>safety endpoints: AEs, SAEs.